Please Wait a Moment
X

Articles

04Jan

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma

04 Jan, 2022 | Return|

On December 28, 2021, the FDA updated the emergency use authorization  (EUA) for COVID-19 convalescent plasma.  The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment.  Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA define acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.

We are currently evaluating our options to determine if we can provide additional testing services using one of the newly defined assays. Please reach out to your customer service manager if your organization is considering CCP testing under the updated guidelines. 

 

 

 

Related

Convalescent Plasma Testing for COVID-19

CTS Tampa has implemented the Ortho Vitros Anti-SARS-CoV-2 Total test which qualitatively detects an...

Read More >

Update on the Ortho Conversion

At CTS, we understand the impact converting to the Ortho viral marker platform has on your operation...

Read More >

Assay History List

We have now added a new section called the "Assay History List" to the "At A Gla...

Read More >

Reminder- Check flights and cargo hours for the Labor Day Holiday

As a friendly reminder, airlines often change their routine flights and cargo hours for holidays. We...

Read More >

FDA Guidance for Industry for Babesia

On May 9, 2019 the Food and Drug Administration issued a “Recommendations for Reducing the Ris...

Read More >

Reminder- Check flights and cargo hours for the Thanksgiving holiday

As a friendly reminder, airlines often change their routine flights and cargo hours for hol...

Read More >